Drafting Manufacturing Small Business 
FDA Law Blog
MARCH 7, 2024
Gibbs — Our last post on small business certification requests described how small medical device manufacturers, defined as those with gross receipts of less than $100 million in gross receipts and sales for the most recent tax year, are eligible for a reduced fee on those medical device submissions that require a user fee.
FDA Law Blog
AUGUST 13, 2023
Specifically, with some exceptions, parties that own or operate a facility engaged in the manufacturing or processing of a cosmetic product for distribution in the United States must list their facilities. In the case of contract manufacturers, either the contract manufacturer or the person whose name appears on the label (i.e.,
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The Process Street
APRIL 22, 2021
What are the business projections? What is the roadmap to achieve the goals – marketing, operations, research and development, manufacturing, and financial plans? Why do you need a business plan? A business plan is not a bag of puffery statements. How to write a business plan. Who are the competitors?
The Process Street
JUNE 30, 2022
You can run the calculations if you’re using your SOPs to govern a manufacturing process, which can be accounted for easily by numbers. You know your business better than I do and can make those assessments. If you’re a small business , this could be an investor, someone from your network, or even a valued customer!
Customs & International Trade Law
DECEMBER 27, 2024
We drafted a persuasive binding ruling request and CBP agreed with our classification and issued a binding ruling reflecting the proposed HTS classification. However, Diaz Trade Law’s claim for prior disclosure treatment was successful andno further penalty was assessed by CBP.
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